The termination of Celldex’s Phase III trial assessing its peptide-based vaccine therapy, Rintega, in newly diagnosed glioblastoma patients, represents a blow to the treatment space as hopes for improved therapies turn instead to Opdivo and drugs combining peptide vaccines with immuno-oncology products, according to analysts with research and consulting firm GlobalData.
In a press release on 7 March, Celldex stated that the trial was terminated because “Rintega has performed consistently with prior Phase II studies but the control arm has significantly outperformed expectations.”
Dan Roberts, PhD, GlobalData’s Senior Analyst covering oncology and haematology, explains: “The fact that this study involved a control arm which outperformed historical controls was not unexpected, as patients who were enrolled in this trial underwent total resection and had no evidence of a progressive disease.”
Indeed, as stated in GlobalData’s glioblastoma report from December 2015, “comparison to historical values must be interpreted with caution, as these patients typically have higher survival than the general glioblastoma population.”
Maxime Bourgognon, PharmD, GlobalData’s Analyst covering oncology and haematology, says that despite Rintega’s disappointments, there are reasons for glioblastoma patients to be optimistic, as immunotherapy agents hold great promise for those faced with high unmet needs and extremely poor survival.
Bourgognon explains: “There are several late-stage vaccines being evaluated for glioblastoma patients, with ImmunoCellular Therapeutics’ ICT-107 holding the highest probability of success. It is also anticipated that the upcoming launch of Bristol-Myers Squibb’s PD-1 inhibitor, Opdivo, in both the newly diagnosed and recurrent settings, will change glioblastoma’s treatment algorithm by improving patient survival.”
GlobalData believes that while peptide vaccines are currently underdeveloped, they hold promise going forward, particularly if they are made up of potential synergistic combinations with active immuno-oncology products which specifically target the immune system, such as checkpoint inhibitors.
Roberts concludes: “Combining peptide vaccines with active immuno-oncology products is scientifically and commercially promising, as these combinations will be able to differentiate themselves in an increasingly crowded glioblastoma market.”